APQP Engineer

L&T Technology Services - Andover, MA (30+ days ago)4.0


APQP Engineer | Andover, MA

Your Job

  • Collaborate on continuous improvement of process and product
  • Design, develop, and support package systems
  • Design, develop, and support package processes
  • Demonstrate high-level performance and deliver high-quality packaging
  • Meet deadlines for scheduling, customer requirements, patient requirement and regulatory requirements

Your Skills & Abilities

  • Bachelor's Degree in Engineering related field
  • 6 years of engineering quality experience
  • 3 years of Class I or Class II Medical Device quality experience
  • Experience in all project phases - emphasis on R&D is preferred
  • Experience in Procurement Engineering and Project Management
  • Experience in Manufacturing & Advanced Product Quality Planning (APQP)
  • Experience managing Supplier Quality - Inspection, Supplier Corrective Action Request (SCAR), 8D Problem Solving, CAPA, Remediation, etc
  • Knowledge of APQP Tools and Methodology - Critical to Quality (CTQ), First Article Inspection (FAI), First Production Inspection (FPI), Process Flow, PFMEA, Control Plan, Process Validation, IQ/OQ/PQ, Production Part Approval Process (PPAP), Process Capability (Cpk / Ppk), Guage R&R, DOE Analysis, etc
  • Medical experience is REQUIRED - medical device preferred, but experience in other health care such as pharma or biotech will be considered
  • Knowledge of FDA GMP standards such as 21 CFR Part 820, 21 CFR Part 11, etc
  • Good teamwork skills - ability to work well with cross-functional teams at all levels of the organization, including third parties such as suppliers, vendors, contractors and customers
  • Excellent communication skills, both written and verbal

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L&T Technology Services is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive due consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status or any other federally protected class.

Job Types: Full-time, Contract

Salary: $45.00 /hour

Experience:

  • APQP: 5 years

Required work authorization:

  • United States